Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

Major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR rate of pembrolizumab as a single agent. Additionally the dynamics of the tumor microenvironment changes on treatment by comparing pre-, on- and post-treatment samples will be evaluated.

Official Title

A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)

Keywords

Non-small Cell Lung Cancer ACZ885 canakinumab pembrolizumab NSCLC non small cell lung cancer early stage NSCLC squamous non-squamous, MPR major pathological response hs-CRP PD-L1 hsCRP surgery neo-adjuvant neo adjuvant CD8 hs-IL-6 CANOPY Lung Neoplasms Carcinoma, Non-Small-Cell Lung canakinumab monotherapy canakinumab + pembrolizumab pembrolizumab monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors.
  • Subject must be eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment).
  • A mandatory newly obtained tissue biopsy from primary site is required for study enrollment. An archival biopsy is also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment.

Note: Aspirates will not be accepted.

  • Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.

You CAN'T join if...

  • Subjects with unresectable or metastatic disease.
  • History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
  • Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening
  • Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization. Control of the disorder with replacement therapy is permitted
  • Subject with suspected or proven immunocompromised state or infections

Other protocol-defined inclusion/exclusion criteria may apply.

Locations

  • University Of California accepting new patients
    La Jolla California 92037 United States
  • Mayo Clinic - Arizona accepting new patients
    Scottsdale Arizona 85259 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03968419
Phase
Phase 2
Study Type
Interventional
Last Updated